Catalog Number 22-4038 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference case (b)(4).
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Event Description
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It was reported that during an arthroscopy, the firstpass capture device fell out of the upper jaw and the device broke inside the patient.The procedure was successfully completed without a significant delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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Additional information in event description.
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Event Description
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It was reported that during an arthroscopy the firstpass capture device fell out of the upper jaw, broke inside the patient.The pieces were removed from the patient with an arthroscopic grasper.The procedure was successfully completed without a significant delay using a back-up device.No other complications were reported.
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Manufacturer Narrative
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H10 h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows a detached suture capture.No manufacturing abnormalities.A functional evaluation revealed the needle will deploy when trigger is initiated, the suture capture is detached and was not returned.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness (3) damage or debris on the device tip between passes.Internal complaint reference: (b)(4).
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Search Alerts/Recalls
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